This trial is active, not recruiting.

Condition tobacco dependence
Treatments smokeless tobacco (oliver twist pellets), smoking cessation counseling
Phase phase 2/phase 3
Sponsor University Hospital, Gentofte, Copenhagen
Collaborator Danish Research Foundation, FSS, Copenhagen, Denmark
Start date April 2006
End date April 2010
Trial size 600 participants
Trial identifier NCT00313105, 2005-004626-10


To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches.

Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Smokeless Tobacco and individual visits
smokeless tobacco (oliver twist pellets)
individual visits with counseling
smoking cessation counseling
individual visits
(Active Comparator)
Nicotine tablets
smoking cessation counseling
individual visits
(Placebo Comparator)
7-mg nicotine patch acts as placebo
smoking cessation counseling
individual visits

Primary Outcomes

Abstinence from smoking after ½ year (point and continuous abstinence)
time frame: 6 months from entry

Secondary Outcomes

Adverse events between 3 arms
time frame: Up to 6 months from entry
Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
time frame: 3 and 6 months from entry
Adherence to study
time frame: 6,12,24 months from entry
Effect of retreatment (abstinence after 1, 1½ and 2 years)
time frame: 12,18 and 24 months from entry
Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status
time frame: 6,12,24 months from entry

Eligibility Criteria

Male or female participants from 25 years up to 70 years old.

Inclusion Criteria: - smokers (>7 cig/day) - Healthy - Allowed: treated hypertension, diabetes treated with tablets, increased cholesterol,other "mild" diseases - mild asthma and COPD, - Motivated to quit smoking - Motivated to follow the protocol - Motivated to use medication in this trial Exclusion Criteria: - Severe diseases - Psychiatric diseases - Used NRT or Zyban the last 2 weeks - Stopped smoking >2 days during last 3 months - More than 6 alcoholic drinks per day - Smokes other products than cigarettes - Pregnant of lactating

Additional Information

Official title Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years
Principal investigator Philip Tønnesen, M.D., Ph.D.
Description This is an open randomized controlled trial with 3 groups testing smokeless tobacco in smoking cessation: 200 smokers will get smokeless tobacco for 3 months, 200 will get nicotine buccal tablets for 3 months and 200 will get 7-mg nicotine patches for 3 months (control arm). After ½, 1 and 1½ a year failures will get smokeless tobacco in the first 2 groups, while only 7 mg nicotine patches in control group until 1½ year where failures in this group also will get smokeless tobacco. Every ½ year cholesterol, blood pressure, lung function and BMI will be assessed and used to enhance adherence of the participants in this trial.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by University Hospital, Gentofte, Copenhagen.